Draft guidance on management of rolling reviews for drug submissions: Performance targets and standards, cancellation

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Performance targets and standards

The time to complete the screening of a drug submission with a rolling review is 25 days. Once the screening acceptance letter is issued, the review 1 period would begin. The submission would immediately be placed on “rolling review” until Health Canada receives all of the missing information, as indicated in the notice.

Once all of the missing information has been received, Health Canada would plan to complete the review of the submission within 180 days (that is, within a 180-day rolling review performance target). This 180-day period, combined with the period the submission is under “rolling review”, would not exceed the 300-day review 1 performance standard for cost recovery purposes.

During the review 1 period, while Health Canada waits to receive the missing information, the submission is considered to be in “rolling review”. Our intent is to start reviewing the drug submission during this period.

During rolling review, Health Canada may request clarification on any of the information or data we have received. Sponsors may ask for an extension for any clarification requests, as indicated in the “pause the clock” process. The processes are outlined as follows:

Extensions granted for sponsors to respond to clarification requests do not change the timelines indicated in the notice of rolling review status for the sponsor to provide missing information. The timeline(s) for providing this missing information is independent from, and not affected by, timelines related to any responses to clarification requests.

The performance standard for cost-recovery purposes for a submission with a rolling review is not changed. The performance standard for that class of submission (for example, 300 days for a “new active substance” submission) is outlined in the following order:

Should a submission with rolling review status fall under a submission class with a performance standard below 300 days, the shorter performance standard would apply. For example, the review of a submission with comparative data as well as chemistry and manufacturing information would be completed within the 180-day cost recovery performance standard. This includes the period during which the submission is in rolling review.

Submission classes with a performance standard of 120 days or less (for example, chemistry and manufacturing data only, labelling only) are not expected to be able to meet the eligibility conditions for a rolling review.

Cancellation (C.08.002(7) or C.08.003(7))

A new drug submission or supplement is considered to be cancelled by the sponsor if the sponsor:

Before cancelling the submission or supplement, the sponsor may speak to the issue.

On an exceptional basis, Health Canada may extend the timeline for providing the missing information beyond 10 days after the dates contemplated in the notice. The sponsor must request an extension in advance and provide a robust justification.

If the submission is considered cancelled, Health Canada will notify the sponsor in writing.

If the submission or supplement is cancelled, the sponsor can file a new submission that includes all of the information required to assess safety, efficacy and quality at the time the submission is filed.

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